510(k) · Cleared
ClearedResolutionMD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calgary Scientific, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 24, 2016 as substantially equivalent to K133508 (Calgary Scientific, Inc., 2014) and 1 other predicate after a 125-day review. Its family tree reaches back 11 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 24, 2016
- Review
- 125 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K954874 (1996). 52 ancestors in all, the oldest K885054 (1989). 4 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations between
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 1 generation backK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
- This deviceK161130 ResolutionMDCalgary Scientific, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK260500 ResolutionMDResolutionMD, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK183248 Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019
- Descendant · cites it directly · 0 of its ownK181185 Change Healthcare Enterprise ViewerChange Healthcare Canada Company · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK162655 StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 9 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 8 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 7 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 6 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 5 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 4 generations backK062163 MimviewerMimvista Corp. · 2006
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 1 generation backK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
- This deviceK161130 ResolutionMDCalgary Scientific, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K260500ResolutionMDResolutionMD, Inc. · 2026 · cites it directly0descendants
- K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019 · cites it directly0descendants
- K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company · 2018 · cites it directly0descendants
- K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −10 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −9 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −8 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −7 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −6 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −5 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −4 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −3 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −1 | K133508 | Resolutionmd Mobile | Calgary Scientific, Inc. | 2014 | — |
| 0 (this device) | K161130 | ResolutionMD | Calgary Scientific, Inc. | 2016 | — |
| +1 | K260500 | ResolutionMD | ResolutionMD, Inc. | 2026 | — |
| +1 | K183248 | Synapse Enterprise Viewer Version 1.0 | Fujifilm Corporation | 2019 | — |
| +1 | K181185 | Change Healthcare Enterprise Viewer | Change Healthcare Canada Company | 2018 | 2 |
| +1 | K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | Medtronic Navigation, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133508 | Resolutionmd MobileSummary page 5…hich Equivalence is claimed Device Manufacturer 510(k) Number ResolutionMD Mobile Calgary Scientific Inc. K133508 ResolutionMD Web Calgary Scientific Inc. K120076 Device Description ResolutionMD® software is an enterpri… | 2014 |
| * | K120076 | Resolutionmd WebSummary page 5…510(k) Number ResolutionMD Mobile Calgary Scientific Inc. K133508 ResolutionMD Web Calgary Scientific Inc. K120076 Device Description ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, a… | 2012 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 52 ancestors have a recall of any class.
- Of its descendants, K260500 (ResolutionMD, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports. ResolutionMD is intended for use as a diagnostic, review, and analysis tool by…
Read the full statement (282 words)
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.
ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations.
ResolutionMD is not to be used for primary mammography diagnoses.
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.
ResolutionMD incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD. It is a tool for use by trained healthcare professionals to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum and minimum lumen diameters and length measurements.
ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations.
ResolutionMD is not to be used for primary mammography diagnoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161130: ResolutionMD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161130
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026